The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough therapy designation for its tyrosine kinase inhibitor (TKI) BAY 2927088. The drug is under review as a potential treatment for unresectable or metastatic non-small cell lung cancer (NSCLC) with activating HER2 (ERBB2) mutations that have progressed following systemic therapy. This decision is supported by preliminary data demonstrating safety, pharmacokinetics, and efficacy from an early-stage trial.
BAY 2927088 has the potential to become the first fully approved therapy in the US for NSCLC patients in the metastatic or advanced setting with HER2-activating mutations. The oral, reversible TKI was developed in collaboration with the Broad Institute, a local academic institution, and is designed to inhibit both mutant human HER2 and EGFR receptors, offering a targeted approach to treatment.
This breakthrough therapy designation by the FDA underscores the significance of BAY 2927088 in addressing a critical unmet need for patients with HER2-mutated NSCLC and highlights the potential of targeted therapies in lung cancer treatment.- Flcube.com
